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Featured Articles

July 2011

David Dills

Writing and Enforcing Your SOPs for GxP Compliance Success - Part 2

by David Dills
Quality & Compliance Advisor

Writing and developing solid operational procedures is a skill that develops over time. Procedures are usually fairly technical and often describe complex subjects. These procedures are reviewed by subject-matter experts, as well as by internal and external auditors and by employees at all levels of the organization. Therefore, it is important to consider the language used when communicating an idea.

Terms like "must," "shall," and "will" indicate steps within a procedure that must be adhered to exactly with each execution. Avoid words that cause ambiguity. Words such as "periodically," "generally," "may," "should," and "can" typically indicate a preference and do not enforce consistent execution.

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Preparing for a Safety Inspection

by Steve Jolley
Subject Matter Expert, Global Safety Compliance and Signal Detection

Large and small pharmaceutical companies alike face a growing and complex set of international regulations designed to protect patient safety and ensure Good Pharmacovigilance Practices. Inspectors from FDA and European regulatory authorities are increasing their efforts to verify that companies comply with these regulations. The penalties for non-compliance can be severe, including revoking a product's marketing authorization.

In order to ensure compliance, regulatory authorities conduct inspections of companies' drug safety operations. To prepare for an inspection, companies must perform a thorough drug safety and pharmacovigilance audit. This will assess the company's compliance with applicable worldwide laws, regulations and guidance. Indeed, regulatory inspectors will look for evidence that such an audit has taken place.

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Do you know how to navigate the FDA's website when searching for FDA warning letter information? During the ACRP conference it became apparent that many people, including FDA employees, have a difficult time searching for Warning Letters on FDA's website. This article provides a few simple search tips to help find Warning Letters for GCPs.
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